Quick links to relevant pages on the TGA website
- The ARTG (Australian Register of Therapeutic Goods). Search the ARTG to find if devices you currently use are already listed: https://www.tga.gov.au/australian-register-therapeutic-goods
- Classification Tool. Use this to help you decide what classification your device falls under: https://www.tga.gov.au/sme-assist/what-classification-my-medical-device#109
- FAQs. These Frequently Asked Questions cover many of the main areas of concern and confusion: https://www.tga.gov.au/regulatory-framework-personalised-medical-devices-frequently-asked-questions
- Glossary of Terms. Search this for definitions of terms e.g. Manufacturer, Supplier, Active medical device: https://www.tga.gov.au/acronyms-glossary
- Inclusion Process. This is a step by step guide for Sponsors applying to include a 'kind of device' in to the ARTG: https://www.tga.gov.au/publication/medical-device-inclusion-process
- Kind of medical device. This page explains the characteristics shared by a 'kind of medical device': https://www.tga.gov.au/kind-medical-device
- The Main TGA Overview Document. Here you can download the TGA Personalised Medical Devices Framework document, the key document to read and refer to through out this process: TGA personalised medical devices framework
- Notification Form. Complete this for each 'kind' of medical device you manufacture/supply to include your device/s in the old system: https://forms.business.gov.au/smartforms/servlet/SmartForm.html?formCode=custom-made-medical-
- An Overview of medical devices regulation: https://www.tga.gov.au/sme-assist/medical-devices-regulation-introduction
- Is your Product a medical device? Work it out by using this tool: https://www.tga.gov.au/my-product-medical-device#1
- Transition Form. Complete this before 25 August to apply to transition your device from custom-made to patient-matched: https://consultations.health.gov.au/tga/accessing-transition-arrangements-patient-matched/
TGA webinars
- TGA webinar on 9 February 2021 - This is the TGA's first webinar aimed at providing an introduction to the new regulatory framework for personalised medical devices. On this page you can access the presentation slides, as well as the recording and the transcript.
- ASO webinar with the TGA 16 February 2021 - This webinar presented by the TGA and hosted by the ASO aimed to give members more information regarding the changes, why they are happening now and how the impact of these changes on orthodontists and orthodontic practices. Please click HERE to view the recording. Please note: TGA fees and charges are agreed annually by the Government, not the ANAO. More information about the process is available on the TGA website.
Other
- Information sheet - This is a useful information sheet for members to pass on to your suppliers if they are unaware of the regulatory changes.
